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Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Subjects With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1/PD-L1 Inhibitor Plus Platinum-Based Chemotherapy

NCT07367516•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in subjects with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same patient population.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance.
•Age between 18 and 75 years old (inclusive)
•Eastern Cooperative Oncology Group (ECOG) score of 0-1
•Expected survival \>12 weeks
•At least one measurable lesion per RECIST v1.1
•Laboratory criteria(no hematopoietic growth factor correction within 7 days)：
•* Hemoglobin (HGB) ≥90 g/L;
•* Absolute neutrophil count (NEUT) ≥1.5×10⁹/L;
•* Platelets (PLT) ≥90×10⁹/L;
•* Total bilirubin (TBIL) ≤1.5×ULN;
+6 more criteria

Exclusion Criteria

•Current or History of Other Malignancies
•Subjects with any condition that may compromise venous access for drug administration or blood sampling are excluded.
•Subjects with prior treatment-related adverse reactions that have not recovered to ≤ Grade 1 per CTCAE v5.0 criteria.
•Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose, Scheduled major surgery during the study intervention period, Non-healing wound, ulcer, or bone fracture at screening
•Subjects with any bleeding/hemorrhagic event ≥ Grade 3 (per CTCAE v5.0) occurring within 4 weeks before the first dose are excluded
•History of Thromboembolic Events within 6 Months
•Poorly Controlled Active Viral Hepatitis
•Subjects with active syphilis infection requiring antimicrobial therapy are excluded
•Subjects with any of the following pulmonary conditions are excluded: active tuberculosis, idiopathic pulmonary fibrosis (IPF), organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, symptomatic active pneumonia, or history of interstitial lung disease (ILD) requiring therapy
•History of Substance Abuse or Psychiatric Disorders
+19 more criteria

Locations (30)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Gansu Provincial Tumor Hospital

Lanzhou, Gansu, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guangxi, Guizhou, China

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

Key Dates

Start Date

February 12, 2026

Primary Completion Date

September 1, 2026

Completion Date

March 1, 2027

Last Updated

March 4, 2026

Enrollment

105

ESTIMATED participants

Conditions

Esophageal Cancer

Interventions

TQB6411 Injection

DRUG

Contacts

Feng Wang, Doctor

CONTACT

13938244776 fengw010@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

Inclusion Criteria

Exclusion Criteria

Resilience and Equity in Aging, Cancer, and Health (REACH)

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

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